Wellcome Trust  [to 1 July 2017]
News / Published: 29 June 2017
Zika vaccine research: guidance for including pregnant women
New guidance for including pregnant woman and their babies in Zika vaccine research has been published today. It has been issued by a group of international experts in vaccinology, maternal and child health, public health and ethics.
Zika infection in pregnancy can have devastating effects on normal fetal development. But pregnant women are often automatically excluded from vaccine trials over safety concerns.
The guidelines argue that those most at risk from the virus – pregnant women and their babies – should be at the centre of Zika vaccine development.
What the guidance recommends
The guidance, developed with Wellcome funding, sets out how the research community can ensure that any vaccines developed are made available to those most at risk.
It puts forward three principles, each with recommendations directed at policymakers, funders, researchers, oversight bodies, regulatory authorities and the global public health community.
[1] To pursue and prioritise development of  Zika vaccines that can be used by pregnant women.
[2] To ensure data is collected in time to inform judgments about safety and efficacy of vaccine administration in pregnancy.
[3] To ensure pregnant women have fair access to participate in research studies…
FDA [to 1 July 2017]
June 29, 2017 –
FDA unveils plan to eliminate orphan designation backlog
Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.
As authorized under the Orphan Drug Act, the Orphan Drug Designation Program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases, which are generally defined as diseases that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for clinical trial costs, relief from prescription drug user fee if the indication is for a rare disease or condition, and eligibility for seven years of marketing exclusivity upon approval. A request for orphan designation is one step that can be taken in the drug development process and is different than the filing of a marketing application with the FDA.
Currently, the FDA has about 200 orphan drug designation requests that are pending review. The number of orphan drug designation requests has steadily increased over the past five years…
IVI   [to 1 July 2017]
June 30, 2017, Seoul, Korea
Changes in IVI’s Board of Trustees
The International Vaccine Institute (IVI) today announced several changes in its Board of Trustees (BOT). Three new members will join the Board: Mr. Malcolm Sweeney, Dr. Chris Varma, and Dr. Ros-Mari Bålöw. Each will serve a three-year term, which will take effect on November 16, 2017.
“The new Board members bring diversity and a wealth of experience in areas ranging from global finance to entrepreneurship to international development and cooperation research,” said Dr. Jerome Kim, IVI Director General. “They bring leadership experience from their respective fields, and I am pleased they are joining our board.”
   … Dr. Viveka Persso, who is from the Swedish National Agency for Higher Education was the Swedish representative on the Board since 2012 and also served as Vice Chair of the Board. George Bickerstaff was appointed as Board Vice Chair effectively immediately following Dr. Persson’s departure….
Gavi [to 1 July 2017]
29 June 2017
Gavi welcomes US$ 1.5 million contribution from China Merchants Group
The pledge will support Gavi’s mission to immunise 300 million of the world’s poorest children by 2020.
Beijing, 29 June 2017 – China Merchants Charitable Foundation (CMCF), a charity affiliation of China Merchants Group (CMG) will contribute US$ 1.5 million to Gavi, the Vaccine Alliance, to support childhood immunisation in developing countries in 2017-2019. This multi-year pledge from CMG is the first agreement of its kind signed between Gavi and a private sector company in the Asia Pacific region.
“China Merchants Group has a deserved reputation as a global leader in logistics, supply chain and financial services, and this multi-year pledge underlines the company’s unwavering commitment to making a real difference to the lives of children in developing countries,” said Dr Seth Berkley, CEO of Gavi…
GHIT Fund   [to 1 July 2017]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
Event Report: GHIT Fund Replenishment Press Conference

The GHIT Fund held a press conference at the Kioi conference center in Tokyo on June 1, 2017, announcing its replenishment with a USD 200 million commitment for the next five years (FY2018-FY2022) from its funding partners. The following GHIT Council members participated: Government of Japan (Ministry of Foreign Affairs and Ministry of Health, Labour, and Welfare), Japanese pharmaceutical companies (Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Ltd., Eisai Co., Ltd., Shionogi & Co., Ltd., and Takeda Pharmaceutical Company, Ltd.), and Foundations (Bill & Melinda Gates Foundation and Welcome Trust)….
NIH  [to 1 July 2017]
June 28, 2017
NIH study sheds light on immune responses driving obesity-induced liver disease
Findings in mouse models reveal inflammatory factors that promote liver scarring.
June 27, 2017
Researchers develop microneedle patch for flu vaccination
The patch could be an alternative to needle-and-syringe immunization.
UNAIDS  [to 1 July 2017]
Selected Press Releases & Updates
Press Release
UNAIDS Board seizes opportunities of change to deliver results
Board members unanimously approve US$ 484 million budget for 2018–2019.
GENEVA, 30 June 2017—UNAIDS’ 40th Programme Coordinating Board meeting has concluded in Geneva, Switzerland. Important decisions were taken on redefining the ways in which the Joint Programme works to deliver results efficiently and effectively and continues to advance global efforts to end the AIDS epidemic as part of the Sustainable Development Goals.
The Board affirmed the UNAIDS Joint Programme Action Plan as a way to progressively move towards a refined operating model. The Action Plan strengthens the coherence and effectiveness of UNAIDS’ support to countries and presents clear results and deliverables on joint working, financing, accountability and governance. The Board members also welcomed the final report of the Global Review Panel on the Future of the UNAIDS Joint Programme Model…
Press Release
Germany to double contributions to UNAIDS
The Government of Germany has announced that it will double its funding to UNAIDS in 2017-2018, to €5 million per year. Germany made the announcement at PCB-40.
PhRMA    [to 1 July 2017]
June 27, 2017
More Than 50 Medicines and Vaccines in Development for HIV Infection, Treatment and Prevention
America’s biopharmaceutical companies are continuing the fight to conquer the human immunodeficiency virus (HIV), which can develop into acquired immune deficiency syndrome (AIDS), with 52 medicines and vaccines currently in development to help treat and prevent the infection, according to a report released today by PhRMA in partnership with The AIDS Institute.
Sabin Vaccine Institute  [to 1 July 2017]
Thursday, June 29, 2017
Thank You for Supporting END7! Changes are coming…

It’s been five years since the Sabin Vaccine Institute launched the END7 campaign to end neglected tropical diseases (NTDs). With your support, we mobilized funding to support programs that treated more than 50 million people, helped increase US and UK funding for NTDs and spread awareness of the global NTD burden.

As of June 1, 2017 we are no longer accepting donations for NTD treatment programs but we are working to ensure END7 advocacy efforts continue uninterrupted. We have concluded END7 fundraising activities and are working with a partner organization to continue advocacy for NTD treatment. END7 student advocacy efforts will continue this fall under the direction of another NTD organization, we will share more details about this exciting transition soon.

The Sabin Vaccine Institute, home of the END7 campaign, is dedicated to making vaccines more accessible, enabling innovation and expanding immunization across the globe. We intend to focus our energy going forward on expanding immunization…
MSF/Médecins Sans Frontières  [to 1 July 2017]
Press release
Proposed Executive Order Puts Pharma Interests Over People’s Lives
June 27, 2017
A leaked draft of President Trump’s executive order on drug pricing reveals that the White House will perpetuate policies that have led to a broken biomedical research and development (R&D) system and raise drug prices around the world, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Press release
Doctors Without Borders Urges India’s Modi to Remain Committed to Affordable Medicines During White House Meeting
June 26, 2017
As U.S. President Donald Trump and Indian Prime Minister Narendra Modi meet at the White House today, Doctors Without Borders/Médecins Sans Frontières (MSF) warned that U.S. pressure on India to change its drug regulatory and patent system could result in millions of people in the U.S. and around the world losing their lifeline of affordable medicines. As an international medical humanitarian organization that relies on affordable generic medicines produced in India to run its medical programs in more than 60 countries, MSF urged Modi to stand strong and protect India’s role as the “pharmacy of the developing world.”
DCVMN – Developing Country Vaccine Manufacturers Network  [to 1 July 2017]
DCVMN Annual General Meeting
25 September 2017 to 28 September 2017
Seoul / Korea
European Vaccine Initiative  [to 1 July 2017]
27 June 2017
EDUFLUVAC workshop
“Four years of European research on the development of universal influenza vaccines: what have we learnt, and how can we move forward?”

EDCTP    [to 1 July 2017]
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
28 June 2017
Botswana launch of AMBITION-cm project on HIV-associated cryptococcal meningitis
Almost twenty per cent of HIV-related deaths are directly attributable to cryptococcal meningitis (CM). The AMBITION-cm project was developed to
Industry Watch
:: Takeda and Biological E. Limited Announce Partnership to Develop Low-Cost Combination Vaccines for Low- and Middle-Income Countries around the Globe
Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multi-national company Biological E. Limited (“BE”) to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP) and measles-rubella (MR) vaccines
OSAKA, Japan & HYDERABAD, India–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) and Biological E. Limited (“BE”) today announced that they have entered into a collaboration whereby two licensing agreements to expedite the development and delivery of affordable combination vaccines have been executed. BE will commercialize the vaccine in India, China and low- and middle-income countries where large, unmet public health needs exist.
Takeda has sold both the measles and pertussis vaccines in the Japanese market for more than 20 years. In heavily populated countries like India, where 25.7 million births occurred in 2015, substantial opportunities remain to deliver critical vaccines to those who need them. In the absence of access to vaccines in many parts of the world, this partnership illustrates Takeda’s desire to forge the kind of collaborations needed to overcome this public health challenge in low- and middle-income countries.
“Access to medicines is one of Takeda’s core values, and these agreements align with Takeda’s strategic goals to make high-impact contributions to global public health, either alone or through partners,” said Rahul Singhvi, Chief Operating Officer, Takeda Vaccine Business Unit. “These two agreements along with our current vaccine pipeline underscore our global commitment to address important infectious diseases across the globe.”

Under these agreements, Takeda will conduct a transfer from Japan to BE its existing measles and acellular pertussis vaccine bulk production technology, including the provision of technical services such as support in infrastructure review, training for production and quality control, technical assistance in process development, preclinical study design and production of clinical batch and the first commercial batches…